Dr. Muthu Dhandapani

Dr. Muthu Dhandapani is a global quality and regulatory-affairs leader with more than 21 years of experience across India, the USA, and the EU, building and scaling regulatory, quality, and clinical-development functions for medical device, IVD, and digital-health organizations. He leads end-to-end regulatory strategy for AI-driven cardiovascular diagnostics, remote patient-monitoring platforms, and Class B/C Software as a Medical Device (SaMD), including national deployments under India’s National Health Mission.

He has secured regulatory approvals for more than 40 medical device and IVD products and seven AI/ML SaMD platforms across 67 countries – spanning USFDA 510(k), EU MDR/IVDR, CDSCO, and rest-of-world markets – built ISO 13485-compliant quality systems across GMP facilities, and led regulatory strategy through M&A and IPO cycles with a 100% audit-pass record across NABL, CAP, ISO 15189, WHO-PQ, and GMP inspections. An IRCA-CQI Lead Auditor (ISO 13485 and ISO 27001) and a member of TOPRA, RAPS, QCI, and ASQ, he advises government and industry bodies including AiMeD and ADMI on MedTech policy, mentors bio-incubators and technology business incubators including STPI, and is a recipient of the Indian Achievers Award and the Bharat Vikas Award.